Access Policy for ALS
Orion aims to build well-being in ALS by developing effective new treatments to help patients manage their illness and improve their quality of life.
We are committed to performing high quality trials with oral levosimendan that will be the basis of our product being available for the benefit of as many patients as possible worldwide. For this we rely on sufficient patients being willing and able to participate in those trials, for the possible benefit of all patients with ALS. Unfortunately, not all patients suffering with ALS have the possibility to take part in a trial, and so some may hope for an alternative opportunity to try oral levosimendan treatment before it has been approved by regulatory authorities.
We believe that the most effective way that we can help patients with this very serious disease is to complete our trials as quickly as possible so that, if successful, oral levosimendan can be made rapidly available to all patients, with a full understanding of how to use the drug safely and effectively. The benefit-risk of oral levosimendan in ALS is yet to be clearly established and thus the use of the drug should be limited to controlled conditions as part of a clinical trial. We have therefore taken the difficult decision that we can not provide oral levosimendan to patients not participating in a clinical trial at this time.
We can only conduct the clinical trial with the great support of patients suffering from ALS and their caregivers, for which we are very grateful. Since we understand the immense impact of this disease on all those patients who don’t take part, we will regularly review this decision in case it becomes feasible to provide access to oral levosimendan at a later date.
For additional information about this policy, please contact firstname.lastname@example.org. We will reply as quickly as possible but aim to take no longer than one business week.